Safety and Tolerability of MORAb-022 in Healthy and Rheumatoid Arthritis Subjects

NCT01357759 | Completed Phase 1

• 1 other identifier: MORAB022-001
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 5

Brief Summary

This is a randomized, double-blind, placebo-controlled, single-dose, dose escalation study in healthy male and or female subjects and subjects with Rheumatoid Arthritis (RA) to determine the safety and tolerability of MORAb-022.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Safety to measures to include adverse events, clinical laboratory results, vital signs, ECGs, physical examinations, local tolerability at the infusion site single escalating intravenous (IV) doses of MORAb-022 in healthy subjects and subjects with RA.

  Approximately 113 days

Study Arms (2)

Escalating doses of MORAb-022

EXPERIMENTAL

Subjects with RA will be randomized into Cohorts 8 to 11, with each cohort consisting of five RA subjects per cohort (four active and one placebo).

Drug: MORAb-022

Placebo

PLACEBO COMPARATOR

Subjects with RA will be also randomized into Cohorts 8 to 11, with each cohort consisting of five RA subjects per cohort (four active and one placebo).

Drug: MORAb-022

Interventions

MORAb-022 DRUG

IV infusion of MORAb-022 at increasing doses starting with the minimal anticipated biological effect level (MABEL) which is 0.0085mg/kg.; IV infusion of Placebo (saline)

Escalating doses of MORAb-022

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects age greater than or equal to 18 years and less than or equal to 75 years.
• Subjects with RA diagnosis per the 2010 Rheumatoid Arthritis Classification Criteria per American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR.)
• BMI less than or equal to 35 kg/m2 at Screening.
• Active RA characterized by DAS28 score of less than or equal to 5.1 at Screening.
• Have been stabilized on their current dose (up to 25 mg/week) of methotrexate(MTX) for at least 4 weeks before randomization.

You may not qualify if:

• Subjects with severe active RA and are not on a stable therapeutic regimen at Screening.
• Subjects without significant articular RA.
• Relevant history of significant respiratory disease (e.g., chronic bronchitis, asthma in last 5 years, chronic obstructive pulmonary disease, tuberculosis, interstitial lung disease, such as pneumonitis and pulmonary alveolar proteinosis, as well as significant inhalation exposure to silicon and other substances) that required treatment and/or follow up under the direction of a physician.
• Presence of GM-CSF autoantibodies above normal at Screening.
• Abnormal chest x-ray or PFTs as judged by the investigator at Screening as clinically significant.
• Positive Quantiferon test.
• History of clinically relevant hypersensitivity reactions (e.g., to gold therapy)
• History of medication use that might have carryover effects during the study.
• Previous administration of a GM-CSF modulator within 6 months of randomization, or previous administration of a monoclonal antibody or immunoglobulin fusion protein that is not (or worded as "other than") a GM-CSF modulator within 3 months of randomization.
• Use of any biological therapy other than the test article during the study (informed consent to termination visit)
• Subjects who consume greater than 14 alcoholic drinks per week for males or 7 alcoholic drinks per week for females.
• Weight greater than 120 kg at Screening.
• Use of parenteral and/or intra-articular steroids, immunosuppressants, investigational drugs, and oral anticoagulant drugs within 4 weeks prior to randomization. Oral steroid treatment is permitted if the dosage is less than or equal to 10 mg of prednisone daily, is stable for a minimum of 4 weeks before the study and remains unchanged throughout the study.

Sponsors & Collaborators

• Morphotek: lead

Study Sites (5)

Axis Clinical Trials

Los Angeles, California, 90036, United States

Location

Seaview Jacksonville, LLC

Jacksonville, Florida, 32256, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Pharmaceutical Research Associates Group B.V.

Zuidlaren, Netherlands

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

gimsilumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Alan J. Kivitz, MD, CPI

  Altoona Center for Clinical Research

  PRINCIPAL INVESTIGATOR

• Lydie Hazan, MD

  Axis Clinical Trials

  PRINCIPAL INVESTIGATOR

• Chrysoula Pappa, MD

  Seaview Jacksonville, LLC

  PRINCIPAL INVESTIGATOR

• William M Schnitz, MD

  Lynn Health Science Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2011
• First Posted: May 23, 2011
• Study Start: May 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: November 16, 2015

Record last verified: 2015-11

Locations

NL (1); US (4)